EP2465493B1 - Compositions topiques pour la prévention et le traitement d'irritation des cellules de la muqueuse - Google Patents

Compositions topiques pour la prévention et le traitement d'irritation des cellules de la muqueuse Download PDF

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Publication number
EP2465493B1
EP2465493B1 EP12159243.0A EP12159243A EP2465493B1 EP 2465493 B1 EP2465493 B1 EP 2465493B1 EP 12159243 A EP12159243 A EP 12159243A EP 2465493 B1 EP2465493 B1 EP 2465493B1
Authority
EP
European Patent Office
Prior art keywords
irritation
topical pharmaceutical
topical
cosmetic composition
prevention
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP12159243.0A
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German (de)
English (en)
Other versions
EP2465493A1 (fr
Inventor
Shabtay Dikstein
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Resdevco Research and Development Co Ltd
Original Assignee
Resdevco Research and Development Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Application filed by Resdevco Research and Development Co Ltd filed Critical Resdevco Research and Development Co Ltd
Priority to PL12159243T priority Critical patent/PL2465493T3/pl
Publication of EP2465493A1 publication Critical patent/EP2465493A1/fr
Application granted granted Critical
Publication of EP2465493B1 publication Critical patent/EP2465493B1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/345—Alcohols containing more than one hydroxy group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/42—Amides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/74—Biological properties of particular ingredients
    • A61K2800/75—Anti-irritant

Definitions

  • the present invention provides a new combination of topically active substances, for the prevention and alleviation of cell damage, caused by preservatives, detergents or drugs, used in topical pharmaceutical, cosmetic or veterinary compositions.
  • Topical products include such topically applied substances as cosmetics, over-the-counter and prescription topical drugs, and a variety of other products such as soaps and detergents.
  • Topical products occur in a variety of forms, including solids, liquids, suspensions, semisolids (such as creams, gels, pastes or “sticks”), powders or finely dispersed liquids such as sprays or mists.
  • topical products commonly classified as “cosmetics” include skin care products such as creams, lotions, moisturizers and “treatment cosmetics” such as exfoliants and/or skin cell renewal agents; fragrances such as perfumes and colognes, and deodorants; shaving-related products such as creams, "bracers” and aftershaves; depilatories and other hair removal products; skin cleansers, toners and astringents; pre-moistened wipes and washcloths; tanning lotions; bath products such as oils; eye care products such as eye lotions and makeup removers; foot care products such as powders and sprays; skin colorant and make-up products such as foundations, blushes, rouges, eye shadows and liners, lip colors and mascaras; lip bal
  • topical drugs are many and varied, and include over-the-counter and/or prescription products such as antiperspirants, insect repellents, sunscreens and sunburn treatments, anti-acne agents, antibiotics, topical respiratory agents, ocular drugs such as eyedrops and saline solutions, therapeutic retinoids, anti-dandruff agents, external analgesics such as capsaicin products, topical contraceptives, topical drug delivery systems, gastrointestinal agents such as suppositories, enemas and hemorrhoid treatments, reproductive system agents such as vaginal treatments, oral treatments such as lozenges, and many other products with therapeutic or other effects.
  • over-the-counter and/or prescription products such as antiperspirants, insect repellents, sunscreens and sunburn treatments, anti-acne agents, antibiotics, topical respiratory agents, ocular drugs such as eyedrops and saline solutions, therapeutic retinoids, anti-dandruff agents, external analgesics such as capsaicin
  • topical products include hand, facial and body soaps and detergents and other forms of skin cleansers, as well as household detergents and many other household products such as solvents, propellants, polishes, lubricants, adhesives, waxes and others which are either applied topically or are topically exposed to the body during normal use.
  • topical products contain chemicals which may produce "irritation,” including various inflammation symptoms or signs, when applied to the mucosa.
  • the present invention is directed to compositions for inhibiting the irritation associated with such topical products.
  • the occurrence, frequency and nature of topical-product-induced irritation often varies from user to user.
  • the severity of irritation to the susceptible user may range from subclinical to mild to severe.
  • Typical symptoms of "irritation” include itching (pruritus), stinging, burning, tingling, "tightness,” erythema (redness) or edema (swelling).
  • the irritation response may be due to the direct effect on the skin of certain topical product chemicals or to a response by the immune system directed toward the chemicals alone or in combination with skin components (e.g. antigens).
  • the present invention relates to topical compositions for combating damaging effects of preservatives or other irritants , found, e.g. in multi-dose eye drops, to mucous cells, especially in the corneal cells and simultaneously beneficial to those tissues. It was found that glycerol counteracts corneal cell damage caused by preservatives such as benzalkonium chloride, cetrimonium bromide, sodium ethylene diamine tetraacetate, etc. Not all the polyhydroxy compounds have such anti-irritant properties. Moreover, it is known that isotonic sodium chloride is toxic to the corneal cells, whereas isotonic glycerol is not toxic. ( Follmann, P. et. al. Szemészet 141, 305-308, 2004 [[.]]).
  • Increased viscosity is achieved by high molecular weight (equal to more than 0.5 million Dalton) polymers. Increased spread is achieved by surface active agents, however after chronic use the surface active agents usually have damaging effects. (See Animal Studies,a).
  • the present invention provides topical pharmaceutical or cosmetic compositions for the prevention and treatment of irritation of mucous cells, comprising a combination of:
  • the present invention preferably provides a non-irritant topical cosmetic or pharmaceutical composition for mucous cells, as defined above, for the prevention of cell damage caused by preservatives, detergents or drugs in topically used cosmetic, pharmaceutical or veterinary compositions.
  • a non-irritant topical cosmetic or pharmaceutical composition for mucous cells as defined above, further comprising at least one pharmaceutically active agent in solution, or in suspension but not in emulsion.
  • a non-irritant topical cosmetic or pharmaceutical composition for mucous cells as defined above, further comprising at least one viscosity enhancing agent.
  • Example 1 Moisturizing eve drops
  • Glycerol 1.3 gm. Xylitol 2.2 gm. Benzalkonium Chloride 0.01 gm. NaOH q.s. to pH 7.0 H 2 O to 100 ml.
  • Example 3 Moisturizing eye drops unit dose form for single application
  • Glycerol 1.3 gm. Xylitol 2.2 gm. Sodium diclofenac 0.1 gm. Benzalkonium chloride 0.01 gm NaOH q.s. to pH 7.2 H 2 O to 100 ml.
  • Example 5 Moisturizing anti-inflammatory eye drops unit dose for single application
  • Glycerol 1.0gm. Mannitol 1.6 gm. Xylitol 1.6gm . Sodium diclofenac 0.1 gm. NaOH q.s. to pH 7.2 H 2 O to 100 ml.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Birds (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Ophthalmology & Optometry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Cosmetics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (5)

  1. Composition topique pharmaceutique ou cosmétique exempte de n'importe quelles émulsions huile-dans-eau ou cire-dans-eau pour la prévention et le traitement de l'irritation des cellules des muqueuses, caractérisée en ce que ladite composition comprend essentiellement :
    1,5 - 5,5% de xylitol, myoinositol ou mannitol ou n'importe quelle combinaison de ceux-ci ;
    0,9 - 2,0% de glycérol ;
    moins de 0,01% de sels inorganiques ; et
    de l'eau.
  2. Composition topique pharmaceutique ou cosmétique selon la revendication 1, contenant en plus au moins un agent d'accroissement de viscosité.
  3. Composition topique pharmaceutique ou cosmétique selon la revendication 2, dans laquelle ledit au moins un agent d'accroissement de viscosité est un polymère avec un poids moléculaire égal ou supérieur à 0,5 million Daltons.
  4. Composition topique pharmaceutique ou cosmétique selon la revendication 1, utile pour la prévention et la réduction de dommages cellulaires provoqués par des conservateurs, détergents ou médicaments, utilisés dans des compositions topiques pharmaceutiques, cosmétiques ou vétérinaires.
  5. Composition topique pharmaceutique ou cosmétique selon la revendication 1, utile pour la prévention et le traitement de l'irritation des membranes muqueuses de l'oeil provoquée par des allergies, polluants chimiques ou irritants physiques, se manifestant par une rougeur, un larmoiement, une brulure, une gêne ou une démangeaison.
EP12159243.0A 2005-05-16 2006-05-07 Compositions topiques pour la prévention et le traitement d'irritation des cellules de la muqueuse Expired - Lifetime EP2465493B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL12159243T PL2465493T3 (pl) 2005-05-16 2006-05-07 Kompozycje do stosowania miejscowego do profilaktyki i leczenia podrażnienia błon komórek

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL168603A IL168603A (en) 2005-05-16 2005-05-16 Pharmaceutical or cosmetic composition for the prevention and treatment of irritation of mucous cells or skin cells
EP06728329.1A EP1888024B2 (fr) 2005-05-16 2006-05-07 Compositions topiques

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
EP06728329.1 Division 2006-05-07
EP06728329.1A Division-Into EP1888024B2 (fr) 2005-05-16 2006-05-07 Compositions topiques

Publications (2)

Publication Number Publication Date
EP2465493A1 EP2465493A1 (fr) 2012-06-20
EP2465493B1 true EP2465493B1 (fr) 2013-08-07

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EP06728329.1A Expired - Lifetime EP1888024B2 (fr) 2005-05-16 2006-05-07 Compositions topiques
EP12159243.0A Expired - Lifetime EP2465493B1 (fr) 2005-05-16 2006-05-07 Compositions topiques pour la prévention et le traitement d'irritation des cellules de la muqueuse

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EP06728329.1A Expired - Lifetime EP1888024B2 (fr) 2005-05-16 2006-05-07 Compositions topiques

Country Status (8)

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US (2) US20080207771A1 (fr)
EP (2) EP1888024B2 (fr)
DK (2) DK1888024T4 (fr)
ES (2) ES2433271T3 (fr)
IL (1) IL168603A (fr)
PL (2) PL1888024T3 (fr)
PT (2) PT1888024E (fr)
WO (1) WO2006123324A1 (fr)

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US8324192B2 (en) 2005-11-12 2012-12-04 The Regents Of The University Of California Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract
US8679545B2 (en) * 2005-11-12 2014-03-25 The Regents Of The University Of California Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract
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Also Published As

Publication number Publication date
DK1888024T4 (en) 2015-10-26
EP2465493A1 (fr) 2012-06-20
PL2465493T3 (pl) 2013-12-31
US10660961B2 (en) 2020-05-26
PL1888024T3 (pl) 2013-02-28
EP1888024B1 (fr) 2012-08-29
WO2006123324A1 (fr) 2006-11-23
ES2433271T3 (es) 2013-12-10
ES2393927T3 (es) 2013-01-02
DK1888024T3 (da) 2012-11-26
PT2465493E (pt) 2013-11-11
PT1888024E (pt) 2012-12-04
ES2393927T5 (es) 2015-12-21
EP1888024B2 (fr) 2015-07-15
IL168603A (en) 2011-05-31
US20170354735A1 (en) 2017-12-14
US20080207771A1 (en) 2008-08-28
DK2465493T3 (da) 2013-10-28
EP1888024A1 (fr) 2008-02-20

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